Text Messaging to Improve Adherence to Clinic Visits and Reduce Early Resumption of Sexual Intercourse After Male Circumcision

This study has been completed.

Sponsor:

University of Washington

ClinicalTrials.gov Identifier:

NCT01186575

First Posted: August 23, 2010

Last Update Posted: January 16, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a result, programs have been introduced and scaled up for voluntary medical male circumcision. Kenya leads with the largest expansion of services.

Early resumption of sexual intercourse after MC may have deleterious effects, including higher rates of post-operative surgical complications, and higher HIV acquisition among females in couples that resume sexual activity before certified wound healing. In the context of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from sexual intercourse before complete wound healing would reduce the rate of post-operative adverse events and minimize the risk of HIV transmission from HIV-infected men to their uninfected female partners.

To the investigators knowledge, the effect of reminders delivered via text messaging to promote adherence to clinic visits and abstinence after MC has not been investigated. The investigators propose a randomized controlled trial in which men who will have undergone voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive either the intervention (context-sensitive text messages after circumcision) or the control condition (usual care). This study seeks to determine (a) the effect of regular text messages sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days post-procedure after receiving regular text messages versus usual care within the 42 days post-circumcision; and (c) to identify potential predictors of failure to attend the scheduled 7-day post-operative visit and early resumption of sexual intercourse.

Further study details as provided by Thomas Odeny, University of Washington:

Primary Outcome Measures:

Proportion of men failing to return for a post-operative clinic visit at 7 days. [ Time Frame: 7 days ]

This proportion will be determined by examining each participant's clinic records after their 7th post-operative day. Adherence to this clinic visit will be analyzed as a dichotomous variable.

Proportion of men who report resumption of sexual activity before 42 days post-circumcision. [ Time Frame: 42 days ]

This proportion will be determined by self-report using a brief questionnaire delivered via phone call. The analysis will be as a dichotomous variable, with participants considered as having either 'resumed' or 'not resumed.'

Secondary Outcome Measures:

Time to resumption of sex by study arm [ Time Frame: 42 days ]

Correlates of failure to attend the scheduled 7-day post-operative visit [ Time Frame: 42 days ]

Context-sensitive text messages are sent to men after undergoing circumcision

Other: Text Message

Context-sensitive text messages are sent to men after undergoing circumcision

Other Name: SMS, short message service, text messaging

No Intervention: Usual Care

Usual care after adult male circumcision (no text messages)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Male

18 years or older

Have undergone circumcision on the day they are screened for the study

Currently own a mobile phone with text-messaging capability, and

Have the mobile phone in their possession at the time of enrollment

Able and willing to respond to a questionnaire administered via a phone call

Exclusion Criteria:

Prior participation in a study on male circumcision

Currently participating in other ongoing research studies

Any medical condition or situation exists such that study participation would not be in the man's best interest, as determined by the investigator

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186575